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The Liver Forum aims to advance the regulatory sciences for the treatment of NAFLD/NASH and liver fibrosis by providing a neutral, independent venue for ongoing multi-stakeholder dialogue. Their work facilitates the best science-based decisions on how to study efficacy and safety in real-time by using collective knowledge and experience with therapies for advancing liver disease. In this episode, Executive Director Veronica Miller joins guest Manal Abdelmalek and co-host Jörn Schattenberg (both Steering Committee members) to discuss the Liver Forum and its valuable work.  

Veronica details her fascinating, well-traveled background and the path she has taken from HIV research to the HIV Forum - an experience that defined what a forum could be and do - to work on HCV and eventually NAFLD. After Veronica describes her path to the Liver Forum, Manal and Jörn share theirs. Each panelist is attracted to this opportunity to pool insights and ponder the deepest, most challenging questions in liver disease with colleagues from across a broad range of stakeholder organizations. 

The conversation shifts from how the Liver Forum came to be to its ongoing activities and programs of today. Veronica believes the striking challenge of the NASH paradigm to be surmounting sufficient evidence to move beyond the liver biopsy. Recalling the precise and dynamic developments of biomarkers for HCV and HIV, she notes the fatty liver field struggles in absence of a pathogen. There remains a new set of complexities regarding disease etiology and pathophysiology, the natural course of disease and the resulting divergent strategies for therapeutic approaches. However, she points enthusiastically to the emerging field of omics for its potential to illuminate a myriad of patient-specific biomarkers.

As we all move beyond the logistical limitations imposed by the COVID-19 pandemic, stakeholders can now come together to sieve through huge quantities of emerging data and distill them into lessons that will shape how we diagnose and treat Fatty Liver patients and then monitor the outcomes of these activities. As the panel notes, data collaboration is a key component for such a paradigm shift. Veronica introduces the Placebo Arm Database Project, co-chaired by Manal, whereby completed trials are studied in an effort to determine what predicts the stability of disease versus progression or improvement. Manal elaborates on the efforts made toward understanding placebo cohorts in totality, including predictors of responsiveness and adherence amongst other sources of variability. By pooling a wider net of datasets, she hopes to draw stronger conclusions, assessments and even benchmarks to power and design more effective trials in the future. Jörn comments that while he is interested in the influence of background care, he wonders whether by combining two histologic endpoints, fibrosis regression and NASH resolution, placebo response is effectively reduced. Manal suggests the field needs either an all-encompassing drug or to make allowances to tease out the risks, benefits and alternatives of unique therapies. She then expands on how an understanding of placebo arms can optimize patient selection for trials. From here, Veronica bridges the conversation to include the influence these insights might have on driving drug development before venturing into the imminent future of clinical trial design.

This episode offers a very special glimpse into the conversations and considerations taking place in the background of putting a dent in fatty liver disease. The session ultimately exposes a fascinating window into the creative thinking applied to the varied, complex challenges facing the field.